Average salary: €24,461 /yearly
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- ...Category: Professional All Job Posting Locations: Cork Cork Ireland Job Description: Duties & Responsibilities: NC CAPA Quality System Investigation Process: Supply Chain Implementation Support efficient and effective investigation training/...SuggestedFull time
- ...standard operating procedures. Prepare and track to completion any assigned change requests deviations quality events and associated CAPAs. Develop and demonstrate an active approach to safety industrial hygiene environmental and regulatory compliance. Assist with...SuggestedFull timeContract workWorldwide
- ...positive behaviour. Support investigations into Quality events, including reporting production issues, writing reports and implementing CAPAs, etc. as required. Participate in/Lead cross functional team initiatives. Participate & support site inspections by regulatory...SuggestedContract workWorldwideShift workRotating shift
PSC Biotech Corporation
Cork4 days ago - ...closely with operations and the business functions to ensure quality performance of product and processes. Oversee and approve NC & CAPA, activist and mentor in problem solving and root causing activities. Lead and participate in the development and improvement of the...SuggestedFull time
- ...exercises judgement to evaluate impact and determines appropriate actions Review and approval of GMP internal Deviation investigations and CAPAs Review and approval of GMP external (supplier) investigations Identifies problems and generates alternatives and recommendations...SuggestedPermanent employmentFull timeFor contractorsLocal area
- ...External Audit/Inspections preparation and management processes for the Site (including follow up on audit action completion associated CAPAs and NC Quality approval). Participate in Site risk assessments. Execute site and quality driven improvement projects...SuggestedFull time
- ...Demonstrated experience with trending and analysis reporting Demonstrated knowledge of adverse event reporting complaint investigation CAPA and corrective action processes Demonstrated leadership skills Demonstrated process improvement and management skills...SuggestedFull time
- ...executing validation protocols and managing validation documentation ~ Working knowledge of Annex 11 21 CFR Part 11 and GAMP guidelines ~ Experience supporting investigations root cause analysis and CAPAs ~ Strong documentation and cross-functional collaboration skills...SuggestedFull timeLocal area
- ...qualification and validation phases. Oversee contractor/vendor activities related to CQV execution. Manage deviations, change controls, and CAPAs arising from CQV execution. Interface with project engineering, quality, manufacturing, and automation teams to drive project...SuggestedContract workFor contractors
BioTalent Ltd
Cork2 days ago - ...Prepare and manage quality documentation e.g. SOPs change control documentation quality agreements training materials investigations CAPA etc. Lead and support JLL quality related complaints change controls deviations investigations root cause analysis (RCAs) and CAPAs...SuggestedFull timeFor subcontractor
- ...Operations, Facility Services and Manufacturing personnel to ensure timely closure of Manufacturing challenges and implement effective CAPAs. Note This description is not intended to be all‑inclusive, or a limitation of the duties of the position. It is intended to...SuggestedContract workTemporary workWorldwideFlexible hoursShift work
BIOMARIN
Cork17 hours ago - ...aspects of producing quality products. May conduct or serve as a lead/coordinator of investigations and corrective and preventive action (CAPA) recommendations related to manufactured products. Works with Research and Development during new product start-ups, and establishes...SuggestedFull timeContract workFor contractorsLocal area
- ...including Quality Engineers and Technicians). Conduct investigation bounding documentation review and approval of non-conformances CAPAs and customer complaints. Escalation of quality issues as appropriate Risk Mitigation: Document justify review or analyse whether...SuggestedFull time
- ...Support and provide regulatory input for pharmaceutical quality system deliverables such as batch variation summaries customer complaints CAPA deviations NCMR etc. for the manufacturing site(s). Prepare and submit OPDP NDA and IND submissions and annual reports using...SuggestedPermanent employmentFull timeLocal areaWorldwideFlexible hours
- ...your life. Required Skills: Preferred Skills: Business Savvy Compliance Management Corrective and Preventive Action (CAPA) Cross-Functional Collaboration Developing Others Fact-Based Decision Making Give Feedback Human-Centered Design Inclusive Leadership ISO...SuggestedFull timeFor contractorsFlexible hours
- ...investigations to successful and timely conclusion; provide training and guidance to Laboratory associates in completing OOS/DCT/QN & CAPAs.* Ownership of CAPAs & Audit actions.* Interpret analytical results and resolve technical and/or operational problems; provide technical...Remote workFlexible hours
Alcon MX
Cork4 days ago - ...on key performance metrics (yield downtime cost per unit etc.) and drive improvements based on findings. Support and lead audits CAPA closure and documentation updates to ensure compliance with ISO 13485 and FDA QSR standards. Train and mentor technicians and operators...Permanent employmentFull timeContract work
- ...database Monitor & update OEE downtime tracking system and equipment process logs Completion of non-conforming investigations (NCIs) (CAPAs) & (DCTs) in addition to assisting with Internal/External audits What youll bring to Alcon: Minimum 3 years experience in a...Full time
- ...maintain compliance in complex areas (such as ever-evolving regulatory requirements worldwide). Support audits, non-conformances and CAPAs as needed. Lead small- scale Packaging projects to drive changes across the packaging team. Mentor or supervise technical staff...Full timeTemporary workFixed term contractWorldwide
- ...of their impact on product design quality and performance. Provides technical input to supplier corrective and preventive actions (CAPA) and support implementation of design or specification changes that improve product robustness manufacturability and cost efficiency....Permanent employmentFull timeWorldwide
- ...documentationincluding procedures work instructions forms and training materialsensuring compliance with relevant industry guidelines. Lead NC CAPA and root cause investigations; maintain compliance tracking risk assessments and EHS controls; and stay informed on upcoming...Full timeFlexible hours
- ...patient risk. Supports the planning pipeline of quality improvement activities including initiatives to increase product quality NCR & CAPA resolution reduce cost decrease in-efficiencies and improve risk management Oversight and responsibility to ensure site maintains...Full timeLocal area
- ...as required. Lead investigations for failures of major pieces of equipment to establish causes as required. Complete deviations, CAPAs and Change Controls as required. Develop and maintain a catalogue of standard job plans. Develop and implement department...Long term contractFull timeContract workTemporary workWorldwide
- ...of disability. Required Skills: Preferred Skills: Analytical Reasoning Communication Corrective and Preventive Action (CAPA) Industry Analysis Information Security Auditing Information Security Management System (ISMS) Information Technology (IT) Security...Full time
- ...guidance Provide day-to-day operational support and troubleshooting for DeltaV systems Support root cause analysis, deviations, and CAPA execution Perform basic system administration and maintenance activities Support CSV activities including protocol execution,...
Advanced Manufacturing Tech Solutions (AMTSOL)
Cork22 days ago - ...predictive quality systems which are easily transferable and maintainable in a production environment. Provide expertise for NCs & CAPAs related to new products. Act as a subject matter expert and mentor in problem solving and root causing tools. Support Design for Manufacture...Full timeFixed term contract
- ...consultative and collaborative support on quality related issues; Lead & support investigation root cause and resolution ensuring appropriate CAPA actions implemented to prevent recurrence where relevant; Author track manage change review/approve/authorise relevant documentation...Full timeRelocation packageWorldwide
- ...aspects of producing quality products. May conduct or serve as a lead/coordinator of investigations and corrective and preventive action (CAPA) recommendations related to manufactured products. Works with Research and Development during new product start-ups and establishes...Full timeContract workFor contractorsLocal area
- ...re-qualification audits, as directed. Coordinate and support Customer audits of the ABEC site, as directed. Coordinate assigned CAPA activities (Root cause analysis, short- & long-term corrective and preventive actions) Coordinate assigned Continuous Improvement initiatives...Long term contractPermanent employmentTemporary work
